MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 MRS CONTROL UNIT; BED, FLOTATION THERAPY, POWERED

Model Number P005787RENT02

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the external alarm was disconnected.The external alarm is the source of the bed exit alarm.It is necessary for the p500 to have an effective maintenance program.We recommend that you do annual preventive maintenance.Control unit checks: ¿ the out of bed sensors operate correctly.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2018.The technician reconnected the external alarm to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the alarm is not working.The mattress replacement system was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: P500 MRS CONTROL UNIT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 7809019
• MDR Text Key: 118112993
• Report Number: 1824206-2018-00325
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P005787RENT02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1